Pill printing and identification

ABSTRACT

Method and identification system to keep track of individual pills dispensed to patients in a hospital by scanning a machine readable code assigned to each pill individually. The pills may be individually within single-pill containers. Inventory levels may be adjusted based on the scanning. Prior to dispensing the pills, a verification check may be performed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of Ser. No. 09/432,469 filed Nov. 3, 1999, nowU.S. Pat. No. 6,776,341, issued Aug. 17, 2004, which in turn is acontinuation of Ser. No. 08/866,598 filed May 30, 1997, now U.S. Pat.No. 5,992,742, issued Nov. 30, 1999, which claims priority fromprovisional Ser. No. 60/018,751 filed May 31, 1996 and is acontinuation-in-part of Ser. No. 08/286,785 filed Aug. 5, 1994, now U.S.Pat. No. 6,799,725 issued Oct. 5, 2004.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to a method of distribution of pills and a pillhaving a machine readable code.

2. Description of Related Art

Pills are packaged in containers, from single-pill containers tocontainers that contain thousands of pills. Pills encompass, forinstance, tablets, caplets, gel-caps, and capsules, and contain eithermedication or a placebo. Pills come in a variety of shapes, sizes andcolors to help distinguish one from the other.

Aside from possibly serving as an enticement for children, theconfiguration (shape, size, and color) of pills generally does not giveone supplier or manufacturer a competitive edge over another due to theappeal of the particular configuration in the marketplace. If the pillsof different suppliers contain different medicine, there is no reasonfor them to have the same configuration. If they did, one pill couldeasily be mistaken for the another, potentially leading to disastrousconsequences.

If the pills of different suppliers contain the same medication, itmakes sense for safety reasons to standardize the configuration to avoidthe potential for mix-up in the event of switching between brands. Sucha mix-up may lead to severe health risks and could be lethal.

On the other hand, a brand name may lose market share to a newcomer thatmerely copies the same pill configuration and, in a sense, passes it offas being an equivalent if not identical to the brand name version. Thecompany owning the brand name may have spent years developing andpromoting the outward appearance or product configuration of its pillsto establish good will and may be unable to stop the newcomer fromflooding the market with a cheaper, but identical version to capturemarket share. If sued for wrongful misappropriation of productconfiguration, the newcomer may successfully assert that for publichealth and safety reasons, the configurations should be the same toavoid consumer mix-up between pills containing different medications. Ineffect, the successful newcomer is permitted easier access to gainmarket share, because of the ability to profit from the consumer feelingcomfortable switching brands due to the familiar configuration of thepills that the consumer was accustomed to with the brand name. Indeed,the newcomer's pill may provide the same impression of quality andefficacy as the brand name.

When a product shipped to one distributor finds its way to the territoryof some other distributor in violation of the trademark rights of thatother distributor, the product traveling in this manner is considered tobe gray goods. The distributor who has trademark rights for theterritory into which the gray goods travel may sue to stop such shipmentof product between territories.

One difficulty, however, lies in determining the origin of the goods,particularly if the goods themselves are not marked in such as way as todistinguish them from one trademark territory to another. This has oftenbeen the case with pills. A problem is that although a packagecontaining pills may include a territorial designation code, the pillitself is not assigned such a code and may therefore be easilyrepackaged to hide its channel of distribution. The absence of such acode fails to assist in the identification of the distributor licenseethat was responsible.

Often pill containers are properly marked and sealed so that themanufacturing source can be identified by lot number. Since thecontainer is sealed, one would expect that the pills inside thecontainer match the lot number on the container. Regrettably, as thecost of medication rises, the temptation grows for merchants orsuppliers to substitute some or all of the pills of the container with acheaper generic version, seal the container, and pass it off ascontaining the pills from the original name brand. It is likely that theconsumer will not suspect the switch, although may notice that themedication is less effective than expected. Regardless, the merchantprofits handsomely. The manufacturer of the brand name product, however,in effect loses a sale and, worse, loses some of its good will as theconsumer wrongfully blames the brand name manufacturer for the poorquality over which the manufacturer had no control. If the consumersuffers medically from the switched medication, the integrity of thebrand name is damaged. In addition, the consumer did not get the brandname product for which he or she paid a premium. This problem arosebecause the consumer has no way of checking whether the pills in thecontainer are the proper pills made by the labeled manufacturer.

Some medical institutions handle huge volumes of pills each day. Theiremployees go through the daily ritual of sorting the pills anddispensing them to the appropriate patients in accordance with eachpatient's specific dosage schedule. Mistakes do happen and pills getmixed up, particularly if they resemble each other in appearance. Anyimproperly administered medication can, of course, be life threateningto a patient. If generic versions are being used, then even the level ofidentification often afforded by brand name logo on the pill is absent.This problem arises because the pills may not have markings on them tocorrectly apprise staff of their medical content. If there is anyquestion as to the content of a pill in the hospital environment, thepill is simply discarded. The cost of such discarded pills can only addto the ever increasing cost of medical care and insurance.

During clinical trials that test for efficacy of new medication, aselect group of patients are given active medication, while anothergroup take a placebo pill. It is preferred that these tests be conductedas single-blind or double-blind tests wherein even the doctor whoadministers the medication is not told which pills are active and whichare placebo. However, as the doctor divides the medication consistentlybetween the two groups, recording which patient receives which pill (aseach pill is marked with a letter, number, or color code), the contentof the pills for each patient becomes apparent to the doctor byobserving the health of each particular patient during the trial. Adoctor, following the Hippocratic Oath of medicine, may compromise theclinical trial by giving all the patients only those pills that thedoctor perceives to contain the active medication. Also, the patientsthemselves may assess which pills are placebo and which are active bycomparing the markings on the pills with the apparent effectiveness ofthe particular pill. Eventually, the test taker may become uncooperativeand refuse to take any pill with markings that indicate a placebo,arguing that his or her health warrants taking real medication. Thereliability of the clinical trial diminishes if an insufficient numberof tests are conducted with the placebo.

These problems in clinical testing may lead to delays in gaininggovernment drug regulatory approval. The problem may be especially acutewith life sustaining drugs or cures for otherwise fatal diseases,because patients will become uncooperative when they know that only aplacebo is being given. Here, of course, the problem is that the pillsare marked in such a manner that the human eye can readily distinguishbetween them.

A Pharmacist generally fills all the prescriptions of a customer andthus should know the customer's medical history, which medication thecustomer may take and is currently taking. If a new prescription comesin, the Pharmacist is supposed to check for contra-indications regardingother medication currently prescribed to the customer. Unfortunately,the pills do not have warnings on them to let the Pharmacist know thatfilling the particular prescription may be dangerous if the customer isalready on certain kinds of medication. Too much responsibility isplaced on the Pharmacist and invariably mistakes are made, leading tolife threatening consequences. The problem here is that no markings areprovided either on the pill or container that the Pharmacist couldreadily check to avoid prescribing medically dangerous combinations ofmedications. In some cases, the Pharmacist has access to a computerhaving a software program designed to remind the Pharmacist of potentialinteractions of a particular drug. To activate the program, thePharmacist must type in the National Drug Code pertaining to theparticular drug or its drug name into the computer. This relativelysimple task may sometimes be ignored or misused by Pharmacists.

Once a pill leaves its container, it becomes impossible to check itsefficacy expiration date, its medication contents, etc. unless thecontainer remains accessible. If the container is emptied and lost orotherwise discarded, unused pills will be unidentifiable, particularlyif the pill lacks any brand name identification. It may be dangerous totake such a pill, depending upon the person's particular medicalcondition and the expiration date. The problem arises due to a lack ofinformation on the pill itself.

The current distribution system requires that pills destined foroff-the-shelf sales be packaged in their own sealed container to guardagainst tampering and contamination. The packaging is sized to contain acertain number of pills, from single-pill packaging, to bulk-sizecontainers. This arrangement is necessary because pills are not markedin a manner that would permit the pills to be sorted from others at theplace of purchase or dispensement. Only the containers are adequatelymarked to avoid confusion. Thus, the consumer has little choice inselecting the quantity of medication to purchase.

Persons whose vision is impaired or are blind are most susceptible tomixing up pills if different kinds of pills have the same feel and tasteand such persons do not seek the assistance of others who can see. Suchpersons would find it beneficial to a device or system that assists indistinguishing between pills by relying upon their other senses, inparticular, their hearing.

Keeping track of the efficacy of pills is a labor intensive task,requiring the patient or care giver to manually record when a pill istaken and when its effects wear off. Since the recording process islabor intensive, it is subject to human error and errors in recordingthe proper time. Nutrition may affect the efficacy of medication andrecording information on nutrition is also a labor intensive task. Oncethe record is made, to be of lasting value, it must be stored in a database. This requires some further manual effort in converting the manualentries from a journal into data entries into the computer.

Micro bar code is known. It is about one tenth the size of standard(MF=1) UPC bar code (Magnification Factor (MF)=1). Scanners for readingmicro bar code are available commercially, such as from NeorexCorporation in Japan and Symbol Technologies, Inc. of Holtsville, N.Y.Symbol Technologies, Inc. has developed a 2D, high density bar codecalled PDF-417 and a corresponding scanner. The PDF-417 code isconsidered a high-density code capable of containing more informationper area than standard UPC code.

It would be desirable to identify the source, distributor, medicationcontents and/or potency expiration date of a pill after the pill isdispensed, preferably through a scanner of machine readable code. Whereidentification of the code by reading it directly with the unaided eyeposes a problem, it is preferred that the patterns within the code betoo small to be resolved by an unaided eye.

SUMMARY OF THE INVENTION

According to the invention, the protocol followed by a nurse may includescanning his or her ID badge, room code, and patient ID bracelet uponentering a room using a hand-held scanning wand plugged into a wallconnector which links the scanner to the hospital computer network. Thenurse then scans the medication from pre-printed coded labels in thecase of a liquid medicant, or scans a suspended bar code element locatedin the liquid, as described below, and/or scans the code located on thepill surface, as described above. The network then verifies that thepatient information, the nurse information, the room information and themedication information is correct and authorized and records all of thisinformation in a secured memory storage. The billing computer is updatedto account for the cost of the exact medication scanned and thescheduling computer is interrogated to ensure that the medication isproper and timely (not too early or late) administered. If all iscorrect, a green light or appropriate sound or signal is activated inthe patient's room, signaling the nurse to give the medication. Oncegiven, the nurse transmits a verification signal back to the computer tobe recorded and later used as proof of the nurse witnessing the patienttaking the medication. If the medication is improper, or the nurse isnot on a predetermined list, to or the medication is too early or late,as prescribed by the attending doctor or any other conflict isdetected), an alarm (or other signal) is activated to appropriatesecurity and/or a red stop signal is provided to the nurse.

DESCRIPTION OF THE PREFERRED EMBODIMENT

The contents of pending patent application Ser. No. 08/286,785, filedAug. 5, 1994 is incorporated herein by reference. The term pill isdefined as any type of tablet, caplet, gel-cap, pellet, gum-piece,capsule, or other edible (or at least biocompatible) item that containsany consumable herb, chemical, mineral, vitamin, plant or animalproduct, or drug including an active medication or a placebo. A bar-typecode may be either printed directly on an outer surface of the pill, onanother layer located beneath the outer layer of the pill yet visiblefrom the exterior of the pill, or printed on a label that is secured toany outer surface layer or underlying layer of the pill.

The code may be edible and/or digestible and be part of the medicationcontents of the pill. The pill be made of layers, including an innerlayer, an outer layer and an intermediate layer between the inner andouter layers. This intermediate layer may be formed by printing, such aswith a conventional ink-jet type printer, but is used to dispense inkonto the pill. The “ink” may be any substance including the medicationof the pill and/or a drug such as a time release. Indeed, different“inks” may be used each providing a different time release drug and beinterspersed between different layers.

If the bar code is printed on a label, the label may be made of adigestible substance, such as a protein base material including gelatin,collagen, hard or soft keratin, and other materials including waxes,polymeric materials (water-based or otherwise), sugar based substrate orcertain water-soluble plastics such as polyvinyl alcohol (PVOH), or madeof an indigestible substance including certain plastics, such as MYLARor ethylene-vinyl alcohol (EVOH) sheet or film, so that the label passesthrough the body without damage. In this later case, the label maypermit subsequent analysis in which case the code itself should be madeof a material resistant to the environment within the human body so thatthe code may be read after it leaves the body with stool. Once separatedfrom the stool, the code may be read. The read information may be usefulin verifying to clinical trial testing authorities that the pill in factwas digested.

According to the invention, it is preferred that the patterns of thecodes located on the pills are too tiny and complex for the unaided eyeto discern differences in the patterns of the codes of two pills. It ispreferred that only an optical scanner (or other suitable electronicdevice) be capable of reading such machine readable code. This may be ofparticular help during clinical trials, as discussed below.

One of the problems with clinical trial testing of pills is that aplacebo pill is eventually recognized by those taking it (or thoseobserving the patients) due to the absence of any relief in thepatients' symptoms. Such patients may become uncooperative and refuse toparticipate further in the trials on the basis that the placebo pillsare not helping them at all. When this happens, the reliability of theclinical trials diminishes, because there is no longer any comparisonbeing made with a “control” group of placebo-pill takers.

One solution to this problem may be to set aside a group of codes thatdesignate a placebo and another group of codes that designate the activemedication. In this manner, the placebo takers will be given pillshaving different markings on them and therefore will not be able toassociate a particular code with the absence of effectiveness.Eventually, however, the placebo taker may catch on that the code isbeing changed strictly for his/her benefit and refuse to participate inthe trials any longer.

Regardless of the type of coding used, as a generally rule, the codingscheme will eventually be determined by those involved with clinicaltrials because, each code (or groups of codes) representing activemedication and placebos will be different. Since the codes on prior artpills may be read by the human eye, it is relatively easy to connectwhich codes on which pills yield healthy results in the patients thattake them.

In accordance with the invention, one way to defeat the placebo takerfrom figuring out the code system is to give a false sense of securitythat the pill being taken is the same as that of another whose pill doesrelieve the symptom. Under such conditions, contact between trialparticipants should be encouraged. The false sense of security comesabout by marking both the placebo and the medication with the samereadable code, such as letters and/or numbers. Thus, both participantsbelieve they are taking the same medication, but it only works for oneof them (since the other is taking the placebo).

Marking both with the same code runs the risk that the placebo and themedication pills may be mixed-up with each other by those conducting thetest. To avoid this, a high-density, 2-dimensional micro bar code (suchas PDF-417 from Symbol Technologies, Inc.) is either printed directly onthe pill or on a label secured to the pill and read by a scanner justprior to distribution. The micro bar code can not be read with theunaided eye and is extremely difficult to discern any differences in thepatterns of two codes, so the clinical trial participants (and theirmedical nurses, doctors and clinicians) do not know which is which.

For example, during a clinical trial, a company sends to a doctor atleast two containers of pills, one container contains pills havingactive ingredients, the other, placebo pills. Ideally, the trial is runas a double blind trial wherein neither the doctor nor the patients knowwhich container contains which pills. According to the invention, thedoctor is also given a scanner gun connected to a computer havingmemory. The computer includes a monitor screen and a software program.The software program “asks” the doctor (or assistant) questions directedto the particulars of each patient within the study. At prescribedtimes, the computer will alert the doctor (or assistant) to give aparticular pill to a particular patient from a particular container. Thebar code located on each pill must be scanned by the scanning gun. Thegun is directly connected to the computer and will read the bar codeinformation off of each pill prior to the pill being administered to aparticular patient. The bar code is preferably a 2-dimensional, highdensity-type micro bar code so that only the scanning gun may read thecode and only the computer (following the particular software program)may interpret the code on each pill. As each pill is scanned, thecomputer will read and store the bar code information from the pill andstore the information in its memory. It is preferred that the computerincludes safeguards against tampering so that the information in thememory of the computer may be read only by authorized personal, similarto the function of a “black box” as a data collector in an aircraft.

As the gun scans each bar code form each pill, the information displayedon the monitor screen may be the actual code (shown in numeric form) ormay be another code, as instructed by the software, which indicates tothe doctor or assistant, neutral or misleading information regarding thescanned code of the particular pill.

According to another aspect of the invention, the pill may have a labelwith a bar code, that is removable so that the label may be directlyadhered to a patient's chart, and later scanned into a central computer.Also, the container of pills may have multiple labels that can beselectively removed for placement onto pills within the container. Theselabels may include projecting tabs which facilitate their easy removalfrom the container. The label may be made of paper, plastic, such asMYLAR, or other biocompatible material. As discussed above, the labelmay or may not be digestible, depending on the application.

As discussed above, according to the invention, the code is preferably amosaic code such as a 2 dimension, high density micro bar code, such asPDF-417 developed by Symbol Technologies, Inc. This type of code isessentially impossible to distinguish with the naked eye. Only anappropriate scanner (also available from Symbol Technologies, Inc.) iscapable of deciphering the intricate patterns of each code.

The code may be read by a scanner for the purpose of identifying thesource of the pill manufacture and the distributor responsible for itsdissemination. Such information may be useful in an effort to preventproduct tampering, unauthorized product repackaging and entry of graygoods.

The code may be read by a scanner for purposes of identifying thecontents of the pill. This is useful for verifying information such asthe medication contained within the pill and its potency or efficacyexpiration date. This is done by correlating the code pattern read withinformation stored in a data base pertaining to the code pattern. Such adata base may be from a microprocessor-based personal computer system, adedicated centralized computer system or from on-line services or evenan INTRANET computer network service or an INTERNET computer networkservice or other microprocessor based systems.

According to the invention, emergency personnel at the scene of accidentinvolving a person who overdosed or took any medication, for instance,may quickly use portable bar code scanners to read the code on unusedpills to ascertain exactly what medication was taken in the overdose.This is desirable where the pill container holding the pills is unmarkedor can not be found.

Different types of medication may be harmful if taken in combinationtogether, although safe if taken separately, over a period of time.According to another aspect of the invention, prior to taking differentmedications, therefore, the code on each pill may be read and, by usingappropriate software, the reading system may check for harmfulcombinations when pills are read in succession from the bar codescanner. The system may include the display of information regarding theill effects that may occur if the combination of medication is taken. Inthis way, a warning is provided as a safeguard against taking the pillstogether in combination.

Alternatively, instead of checking pills in succession, a data basestoring information on the medication that a particular patient/consumeris taking may be checked automatically to determine whether taking thenew pill medication in combination with those identified from the database poses any health risk. If so, a warning is issued of the potentialhealth risks.

According to the invention, any machine readable code that is in a formother than human-readable alpha-numeric characters may be used. Such acode may be micro bar code, 2 dimensional codes, 3 dimensional codes,high or low density codes, as long as the particular code may fit onto apill in a manner that allows the code to be read by a scanner. Othercodes that may be used include UPC/EAN/JAN, Code 128, Code 39, CodeInterleaved 2 of 5, EAN 128*, Codabar, PDF417, UPC-A, UPC-E, EAN 8, EAN13, UPC/EAN 128. Each of these codes, if sized according to theparticular pill size would be suitable for use on pills in accordancewith the invention.

If PDF-417 micro bar code is used, according to the invention, a codewith dimensions of about 8 mm long and about 4 mm wide may convey up to10 digits of addressable information. This information may be actualdata, such as an expiration date, National Drug Code, or lot number forthe particular medication, or may simply be an address that directs auser to additional data located in a data base, including date ofmanufacture, the identity and location of the manufacturer, recommendeddosage, dietary and related drug-usage information, contraindications,and the recommended price of the medication.

High density bar code is the preferred coding scheme, according to thisinvention, because it may be read quickly and accurately and may conveya great number of characters in very little space. The reasonalpha-numeric characters are excluded for this invention is because theyhave been printed onto pills for many years and because they conveyinformation in a spatially inefficient manner. A pill has a smallsurface area that does not lend itself to supporting many alpha-numericcharacters. Also, pattern recognition software, while capable ofrecognizing alpha-numeric characters, deciphers the alpha-numericcharacter code slower and less reliably than would a bar code typescanner deciphering a bar code.

Even the alpha-numeric character readers require that the entire patternbe read (as opposed to a cross-section as would be the case whenscanning vertical bar code lines) so that the pills must be oriented ina particular manner and held in that position while the scannercompletes its scan. By using codes other than those containingalpha-numeric characters, therefore, both the reading time anddeciphering time is faster and the orientation of the pill relative tothe scanner is somewhat more flexible. For instance, reading analpha-numeric character string upside down or sideways may cause someproblems for pattern recognition software (e.g., M versus W and U versusC), but causes really no problem for bar code readers that can scan inmany directions very rapidly to check for vertical bar code lines. Byalpha-numeric, oriental characters and symbolic languages are alsoenvisioned in addition to the alphabet and numbering system.

Up to now, there has been little incentive to develop scanners forreading at the micro bar code level. Since pills are three dimensionalobjects whose surfaces may or may not be flat and may or may not beoriented in a particular manner relative to a scanner, the preferredembodiment of a scanner is one that rotationally sweeps rapidly at leastup to 180 degrees to ensure that the full code is read no matter thepill's orientation. It is assumed, of course, that the surface of thepill bearing the micro bar code faces the scanner and the scanning beamis aimed at the code. If this may not be the case, then multiplescanners (or one scanner and one or more mirrors) should be used, eachpositioned so that the full surface area of the pill will be scanned.

Another application of the invention includes a quick cross-checkbetween the pills and their container. By comparing the code on eachpill after scanning with an appropriate machine code reader for amatching pattern, a determination can be made readily as to whether thepills originally belonged in that container. Additional safeguards canbe incorporated into the pill code, such as hidden code portions thatare invisible to the naked eye or even if aided with a magnifier (e.g.,only visible under infrared or ultra-violet light). The presence orabsence of such hidden code portions within the code on the pill mayhelp counter unauthorized or unintentional exchanges of pills in acontainer. A pill container, according to another embodiment of theinvention, is made from (either entirely or in part, defining a scanningwindow) a material, such as plastic that permits at least one pilllocated therein to be scanned using a scanner located outside thecontainer. In this manner, pill information may be decoded from theactual pill without opening a sealed container.

In another embodiment, the scanner has a built-in clock, or is connectedto a clock (for example, through a computer), and the time the pill isscanned (and presumably the time the pill is taken) is recorded. Thisinformation helps assess the track record of the pill's efficacy and theconditions under which the pill was effective or ineffective. Thescanning equipment may be connected via an electronic link-up to anon-line service or the INTERNET, and suitable software may automaticallyforward the statistical data gathered by the readers to a centralizedcompliance monitoring system or to a centralized evaluation center.

Often, nutrition plays a role in the efficacy of a medication. Recordinga patient's diet before and after taking a medication (e.g., a pill) isa labor intensive task. Once obtained, it must be painstakinglyconverted as a data entry into a computer data base for storagepurposes, but unless the record keeper is meticulous, the value of thedata is subject to human error.

At present, catalogs are available that include a listing of productsand, next to each picture (or listing) of the product, is acorresponding bar code. A consumer may scan the bar code to initiate anorder for delivery of a selected product. In accordance with theinvention, a similar concept may be applied to record dietaryinformation of a patient before, during and after a pill is ingested.

According to the invention, a book is provided for the patient's usewhile following a medication schedule. The book contains pictures ofdifferent types of foods with an associated bar code next to eachpicture. The above-described micro bar code scanner/reader that readsthe micro bar code on the pill is used to read the bar code in thecatalog associated with a selected food item. If the reading iscorrelated with the time of day, such as with an electronic clock inelectrical connection with the micro bar code scanner/reader,information may be recorded concerning the pill taken and the food itemeaten and the time of day when both were taken. If the patient isinstructed to take the medication as soon as the benefits wear off fromthe last medication taken, then the information would represent somemeasure of the efficacy of the pills. Since all the information is indigital form, no manual labor is necessary either to record the pilltype, quantity, time of day or food items eaten. A statistical profileon efficacy is automatically generated and, when combined with profilesconcerning the same medication but taken by other patients, a fairlyreliable indicator of the duration of efficacy and the nutritionaleffects on efficacy is realized.

Alternatively, if a patient is instructed to take pills at set intervalsthroughout the day, provisions could be made for the patient to actuatea signal indicative of when the medication started to take effect andanother signal indicative of when the medication efficacy ended. Such asignal could be generated by actuating a key on the scanner/reader. Theactuation of the key would be tied into the electronic clock that runsto record the time of day when the code on the pill is read.

In addition, the scanner may read the bar code on the pill container, inthe same manner as it is capable of reading micro bar code on a pill (asdescribed above), and store the scanned information into a data base,yet avoid the need to manual record keeping on pill efficacy. Under suchcircumstances, the pills would not require micro bar coding because therecord keeping could be done by reading the bar code on the container.

If the user of the scanner/reader makes a mistake, an error button couldbe actuated to retract entry of the last key actuation and substitute itby the next key actuation. The reader may have a speaker to enunciateconfirmation of what was read.

The operation may be as follows:

(1) Patient or care provider scans code on pill with the reader. A beepsound is enunciated by the reader to confirm recognition of reading ofthe code.

(2) The patient scans code associated with the food/drink item consumedif any. The scanning may be of a food group containing the food/drinkitem or may also include scanning a quantity of the food/drink itemconsumed.

(3) An electronic clock is used to help record the time of day when thescanning of the codes took place. The scanner preferably contains thisclock.

(4) The patient actuates a button when the pill works and actuatesanother button when the medication from the pill wears off. The time ofday for both events is recorded based on the time of day being trackedby the clock.

(5) After an entry is made, confirmation is enunciated through speakersof the scanner.

(6) Immediately after making a mistake in actuating, the mistake may beremoved entirely by actuating yet another button and then enteringanother entry as a substitute.

(7) All the scanned information may be used to establish a data base.Each scanner, therefore, may be given its own electronic identity codethat is stored along with whatever other information is retrieved frommemory of the scanner.

(8) The buttons of the scanner may have different colors, sizes andshapes to help distinguish between them. For instance, the buttonassociated with signifying that the pill is taking effect could be greenwhile that signifying that the pill no longer is taking effect could bered. The scanner could have a light that illuminates after one of thebuttons is actuated and remains lit until the other button is actuatedto serve as an indicator of the last button actuated. The reason forgiving the buttons a different shape and size is to help visuallyimpaired persons distinguish between the buttons. The error button couldbe a different size, shape and color from the other buttons.

By distributing such scanners to a large number of patients, there willbe an ever increasing amount of information collected and stored indigital form. When combined together, statistical profiles could begenerated to show how long different types of pills remain effective andunder what circumstances they remain so, i.e., the relationship betweenpill effectiveness and nutrition could be depicted graphically. Theconcentration of medication in the pills could be varied and the effectof this variance on how quickly the pill takes effect and lasts could beanalyzed from the data collected. Based on such analysis, the optimalconditions for taking medication could be determined. Other factors,such as the weight of the patient, that may affect how quickly the pillworks and lasts could also be entered as data by being programmed intothe scanner, preferably to read out automatically with the scanneridentification number.

Since the scanner identification number is stored in association withinformation read from or entered into the scanner, any aberrations couldbe easily screened out from the statistical analysis to remove theeffect of such information whose reliability is suspect. On the otherhand, doctors or health care providers could retrieve informationpertaining to a particular patient, analyze it, and change themedication accordingly as warranted by the analysis.

In addition, the scanner could be interactive in the sense of warningthe patient that taking whatever was just scanned may not be recommendedmedically or may not be optimal. For instance, some studies suggest thattaking grapefruit juice with pills helps to quicken the pill'sabsorption into the body because of its acidity while other drinks, suchas apple juice, may have the reverse effect (because of its sugarcontent). Thus, if apple juice is scanned, a warning could be made bythe scanner to recommend avoiding the selected type of juice and chooseswitch a different type of juice.

In view of the many different kinds of foods, it may be simpler for thepatient to scan a bar code next to a picture of the particular type offood group instead of the actual food/drink item. On the other hand, ifthe patient regularly consumes the same food more often than not whentaking the medication, this could be automatically programmed to speedup entry of information, e.g., unless the patient actuates a button, itwill be assumed that the patient is taking the same type of juice withthe pill.

Labeling the pill with micro bar code may be done in any conventionalmanner, such as is taught in marking a logo or code on a label andapplying the label to the pill according to U.S. Pat. No. 4,478,658,whose subject matter is incorporated by reference. Of course, theadhesive, if any, and the ink, if any, should be non-toxic and otherwisebiocompatible. Conventional water-based inks such as food coloring maybe used.

It is preferred that the machine-readable bar code is printed onto acode-receiving layer made from a protein based film, such as keratin andgelatin, which is, in turn, adhered to the surface of the pill,preferably using water. Application of water, in a controlled manner,partially dissolves the water-soluble gelatin or keratin film andadheres the code-receiving layer to the surface of the pill. It ispreferred that the code-receiving layer is “established” or formed onone surface of an appropriate release backing. The release backing isused to support the delicate protein-base code-receiving layer, as thecode-receiving layer receives the bar code ink and is later applied tothe surface of the pill. After a bar code is printing onto one exposedsurface of the code-receiving layer, the release backing is pried awaythereby leaving the code-receiving layer (with the code printed thereon)adhered to the surface of the pill. It is preferred that another layer(such as one made from gelatin) be located outside (on top of) thecode-receiving layer to protect the printed code from the environment,in particular, moisture and abrasion.

Uncoated tablets differ from capsules, caplets, gelcaps and coatedtablets in that their outer surface is porous and is not sealed orhardened as is the case for these other types. When the outer surface issealed or hardened, it is easier to print with wet ink onto the surfacedirectly or adhere a label to its surface than for a porous outersurface of an uncoated surface. It such instance, a portion of the outersurface of the uncoated tablet is sprayed (or otherwise coated) with asubstance to aid in the printing onto the tablet or adhering to thetablet. The substance may be made from a material based on sugar, wax,gelatin, keretin, collagen, polymers or protein.

Some conventional techniques of suitable printing on uncoated tablets oruncoated tablet cores include U.S. Pat. No. 4,548,825, issued Oct. 22,1985 to Voss et al. and entitled METHOD FOR INK-JET PRINTING ON UNCOATEDTABLET CORES, and U.S. Pat. No. 5,006,362, issued Apr. 9, 1991 toHilborn and entitled BRANDING PHARMACEUTICAL DOSAGE FORMS, FOOD ANDCONFECTIONERY PRODUCTS WITH AQUEOUS INGESTIBLE INKS. Printing ahuman-readable symbology onto machine-readable symbology is known fromU.S. Pat. No. 4,889,367, issued Dec. 26, 1989 to Miller and entitledMULTI-READABLE INFORMATION SYSTEM and may be applied as well. Further, asuitable code reading system for reading invisible bar codes isdisclosed in U.S. Pat. No. 5,331,140, issued Jul. 19, 1994 to Stephanyand entitled CODE READING SYSTEMS. The contents of each of these patentsis incorporated herein by reference.

In accordance with the present invention, any type of machine-readablecode including micro bar code, holograms, two or three dimensionalmachine-readable codes, and other high-density codes, is imprintedeither directly or indirectly onto the surface of a medication tablet orcapsule (i.e., pill). The type of ink or coating material used toimprint the machine-readable code on the pill is non-harmful (i.e.,biocompatible) to humans (and/or animals) when digested and furthermoreis machine readable by scanning equipment, i.e., meets the minimumabsorption requirements of bar code reading. The code pattern is eitherprinted directly on the pill, or is first printed on a carrier orcode-receiving layer, as described above, such as paper, thin plasticfilm (e.g., PVOH or EVOH), a protein-based material, such as gelatin andkeratin film or related collagen-based films, or a biocompatiblepolymeric sheet or film. The carrier is then preferably applied to thepill during the manufacturing process, as described above, or at a latertime, perhaps by a doctor, nurse, or pharmacist, depending on thespecific application of the invention.

According to another embodiment, the ink or coating used in making theentire code, or a predetermined portion of the code, is machine readablein non-visible wavelengths and is otherwise invisible to the human eye.Invisible codes on medication tablets (or capsules) provides a highlevel of tamper-proof security and control of the medications.

The specific location of the code on the pill will vary depending on thetype of code used, the type of scanner used to read the code, and thesize, shape and type of the pill being coded. For capsules wherein twointerfitting hollow shells made from a bio-compatible material (such asgelatin) are used to contain a prescribed dosage of a drug, the code iseither printed on the exterior surface of either capsule or on theinterior surface of either capsule (assuming that the code may bescanned through the capsule material) or on both the exterior andinterior surfaces wherein a preferably simple, special tamper-proof code(invisible or visible) is located along the interior surface. Coding theinterior capsule shell wall prevents accidental or deliberate damage ortampering of the code. Codes located on the exterior surface of the pill(regardless of the type) are preferably protected against abrasion ortampering by a clear coating or layer. This layer may function as thecarrier substrate material wherein the code is located on a rear surfaceof the carrier substrate material.

In accordance with the invention, pills are of the type that are coatedtablets (such as an Advil brand tablet); again the code may be eitherdirectly imprinted on the hard exterior shell using the same technologyused to print the logo of the manufacturer or name of the medication(such as “Advil”), or a carrier material, as described above, may beused. In either case, either the carrier material or the exterior shellof the tablet (or capsule) must meet the requirements for the scanner toeffectively and accurately read the code (i.e., the difference inreflectivity between the ink (the bars in a bar code, for example) andthe carrier surface (the spaces in a bar code, for example) is at leasta minimum percentage. These minimum scanning requirements are known bythose skilled in the art.

In accordance with the invention, pills of the type that are non-coatedtablets, such as aspirin or Rolaids brand antiacid medications or areotherwise porous and/or have a chalk-like exterior surface, a “patch” ofa non-absorbent bio-compatible material in the form of a coating orapplied film, such as a wax, gelatin, keratin, collagen, other proteinbased materials, polymeric films, EVOH or PVOH is first (orsimultaneously) applied to a predetermined location on the exteriorsurface of the pill. The code may then be directly applied to thenon-absorbent patch. The purpose of the patch is to provide a surfacefor carrying the ink used to make the machine-readable code meeting theabove-described reflectance requirements. The above-described carriermaterial supporting a pre-printed code may also be used with suchnon-coated pills in place of, or in addition to the above-describedapplied patch. Furthermore, the ink or coating material used to conveyor imprint the code on non-coated type pills may be a non-spreading typeink adapted to be directly applied to chalky surfaces without losingresolution of the code.

In accordance with the invention, the code is preferably imprinted insuch a manner to be easily machine readable by an appropriate laserscanner. The orientation of the code will depend on the type and shapeof the pill. For example, elongated, cylindrical capsule-type pills mayinclude a code that is made up of bars which completely surround theexterior of the pill following the longitudinal axis. In thisarrangement, the capsule-type pill may be easily directed down atransparent chute or pipe and be simultaneously read by a single scannerlocated adjacent to the chute or pipe.

For ovaloid-shape pills (i.e., pills shaped like an M&M candy), the codemay be imprinted on either or both sides, and include concentric ringsof varying thickness bars and spaces, depending on the type of code. Inthis case, the chute may be elliptical in cross-section to receive andguide this type of pill. Again, one or more adjacent scanners. may beused to read the code as the pills pass through the chute. The mostefficient location of the bar code on the surface of a pill may bedetermined by one skilled in the art of bar code scanning.

In accordance with another embodiment of the invention, the ink used tomake the code and the carrier material used to carry the code may beintentionally made of a non-digestible material so that afterconsumption of a particular coded medication, the information conveyedby the code will be passed by the patient. The code may then berecovered from the patients excrement, treated as necessary (i.e.,washed), and scanned. This particular embodiment of the invention isuseful in clinical studies where patients either consume severaldifferent types of medications during a trial period and/or consume oneof either a placebo or active pill. Since the codes of this embodimentare not destroyed after the pill is consumed, the information encoded onthe pill prior to consumption may be later extracted to investigatesymptoms or fatalities of the patient or to check the integrity of thestudy (i.e., to ensure that the patient did take the prescribedmedication). The above-described embodiment could also be applied to alltypes of over-the-counter and prescription pills. In this manner, anydeath or unexplained illness to any human or animal due to a consumedmedication or drug could be easily and quickly investigated oraccurately treated. Furthermore, should the quality of a particularmedication be at fault, the entire lot or related batch of themedication could be isolated and further illness prevented.

According to another embodiment of the invention, a container isprovided to transport and dispense a plurality of pills in bulk.Manufacturers use the containers to supply pills to hospitals, forexample. The containers are sealed and are tamper-proof prior to andupon arrival at the hospital. Each container is adapted to be receivedinto a dispensing machine. These dispensing machines are locatedthroughout the hospital (e.g., emergency room, supply room, etc.) andare lockable. Once locked, the containers located within open to allowtheir contained pills to be dispensed in a controlled manner from themachine. In operation, the dispensing machine first receives anauthorization code from a keypad (as typed in by a nurse, for example)or scanned in information from a bar code located on a nurse's ID badge.The user then inputs a patient or medication request code and thereaftereither selects and/or receives the proper pill combination from thevarious containers located within the machine in an appropriatetransportable, preferably sealed, and perhaps tamper-proof container.Just prior to being dispensed, each selected pill traverses an internalchute wherein an information code located on the pill is machine read.The information of the code of each selected pill is sent to a localcomputer or local area network to verify the request, update billing,and verify and update scheduling for the particular patient. If therequest is verified and approved, the pill (or pill combination) isreleased from the chute. Otherwise, the pill is diverted to an internalholding bin which is not-accessible to the user of the machine.

The purpose of the above-described dispensing machine and sealablecontainer is to keep track of each pill within the hospital and to savethe expense of individual packing. Furthermore, since the exact numberof pills sent to the hospital is known, the number of pills remaining isalso known. Such information may be transmitted to the hospitalsinventory computer to automatically signal appropriate personnel toreload a particular container prior to it becoming completely empty,and/or signal the pill supplier to send another bulk loaded container.In either case, no one has direct unaccounted access to the medication.Tampering and pilfering of medication is either prevented or evidentonce it occurs.

Once dispensed, the nurse may enter a patient's room and administer themedication. According to the invention, the protocol followed by thenurse may include scanning his or her ID badge, room code, and patientID bracelet upon entering a room using a hand-held scanning wand pluggedinto a wall connector which links the scanner to the hospital computernetwork. The nurse then scans the medication from pre-printed codedlabels in the case of a liquid medicant, or scans a suspended bar codeelement located in the liquid, as described below, and/or scans the codelocated on the pill surface, as described above. The network thenverifies that the patient information, the nurse information, the roominformation and the medication information is correct and authorized andrecords all of this information in a secured memory storage. The billingcomputer is updated to account for the cost of the exact medicationscanned and the scheduling computer is interrogated to ensure that themedication is proper and timely (not too early or late) administered. Ifall is correct, a green light or appropriate sound or signal isactivated in the patient's room, signaling the nurse to give themedication. Once given, the nurse transmits a verification signal backto the computer to be recorded and later used as proof of the nursewitnessing the patient taking the medication. If the medication isimproper, or the nurse is not on a predetermined list, to or themedication is too early or late, as prescribed by the attending doctoror any other conflict is detected), an alarm (or other signal) isactivated to appropriate security and/or a red stop signal is providedto the nurse.

U.S. Pat. No. 5,502,944, issued Apr. 2, 1996 to Kraft et al., entitledMEDICATION DISPENSER SYSTEM is incorporated by reference. It teachesautomating the dispensement process with robotics manipulating aselected container to transfer medication units from the containerdirectly to the package. Medication is directly transferred from thecontainer to the package so that no cross-contamination occurs. Thepresent invention may be incorporated into this teaching by use ascanner that reads the machine readable code on pills to make theappropriate identification for the robotics manipulation.

Another embodiment of the invention incorporates a bar code onto anelement that is suspended into a liquid. The element may be a smallstrip of clear or white MYLAR (or other suitable) plastic. A pluralityof these elements are placed into a container of liquid. As the liquidis poured into a dispensing cup, at least a portion of the suspendedelements, each bearing identical bar code information also enters thedispensing cup. Preferably, the elements are invisible or at leastbarely noticeable to the naked eye so that the patient drinking theliquid will not see, taste, or feel the elements in the liquid as theliquid is swallowed. As any given moment, the liquid in the dispensingcup may be scanned by a bar code laser-type scanner. The laser beam willeventually read one of the many elements in suspension in the liquid andthe information conveyed in the form of the bar code will be read andunderstood.

According to an embodiment of the invention, a pill has an outer surfacethat includes a machine readable bar code

According to another embodiment of the invention, a pill has atransparent layer defining an outer surface and an inner surface. Thepill includes a machine readable bar code on the inner surface under thetransparent layer.

According to another embodiment of the invention, a pill includes alabel having an outer surface and an adhering surface. A machinereadable bar code is located on the outer surface of the label. Theadhering surface of the label is adhered to an outer surface of thepill.

According to another embodiment of the invention, a pill includes alabel having an outer surface and an adhering surface. A machinereadable bar code is located on the outer surface of the label. Theadhering surface is adhered to an outer surface of the pill. At least aportion of the bar code is only readable using a wavelength that islocated outside the visible spectrum (i.e., not visible by a human eye).

According to another embodiment of the invention, an element made from abiocompatible material has a printable surface onto which a micro barcode is printed. At least one, preferably many elements are suspendiblein a liquid. The bar code information located on each element may beread through the liquid.

According to another embodiment of the invention, a medication dispenserincludes at least one supply chamber for receiving a bulk-container ofpills, a chute through which selected pills may be dispensed, a controlgate located adjacent to the chute for controlling the transport of apill into the chute, and a scanner adapted to read bar code. The controlgate is connected to and controlled by a computer. Each pill has amachine readable bar code. Prior to being dispensed, a pill is guidedthrough the chute past the scanners so that the bar code informationlocated on the pill may be read and the information sent to thecomputer.

According to another embodiment of the invention, a pill includes amachine readable bar code. The bar code includes a pattern that has adimension and complexity that prevents (or otherwise discourages) ahuman to distinguish, at a glance, any difference within the patterns oftwo or more pills.

1. A method of verifying that medication to be administered is correct,comprising: scanning a bar code on an identification bracelet worn by apatient to ascertain patient information; scanning a bar code pertainingto medication to be administered to the patient to ascertain medicationinformation; verifying whether the patient information and themedication information is correct and authorized based on both of thescannings by accessing a network; and activating an alarm if theverifying indicates that the medication is improper for administrationto the patient.
 2. A method of claim 1, further comprising notifyingthat the medication may be given to the patient provided the verifyingfinds that the patient information and the medication information iscorrect; and transmitting a verification signal upon witnessing that thepatient was administered the medication subsequent to the notifying. 3.A method of claim 1, further comprising scanning a nurse's badge, andusing the network to verify that nurse's information scanned from thenurse's badge is correct and authorized.
 4. A method of claim 1, furthercomprising updating billing to account for a cost of the scannedmedication.
 5. A method of claim 1, wherein the verifying includesinterrogating a computer with scheduling to determine whether themedication is being administered too early or too late.
 6. A method ofclaim 1, wherein the medication is contained in pills that are sealedindividually within single-pill containers.
 7. A method of administeringmedication, comprising: keeping track of each individual one of aplurality of pills by machine reading a machine readable code assignedto each of the individual pills; dispensing an individual one of thepills based on the machine reading; and adjusting inventory requirementsfor stocking of the individual pills based on the machine reading andthe dispensing.
 8. A method of claim 7, further comprising verifyingprior to dispensing that the individual pill is scheduled to be taken bythe particular patient by checking with scheduling information stored ina computer.
 9. A method of claim 8, further comprising billing a costfor the individual pill based on the machine reading and the verifying.10. A method of claim 7, wherein the pills are individually withinsingle-pill containers prior to the dispensing.
 11. A drugidentification system for marking solid form drugs comprising a pillimprint having a first marking in the form of a human recognizablesymbol and a second marking in the form of a machine readable bar code,wherein the human recognizable symbol provides a general identificationsuitable for categorical identification and communication, and themachine readable bar code provides an item identification.
 12. The drugidentification system of claim 11 wherein the bar code is a 2D bar code.13. A method of determining information concerning a pill, comprisingdispensing pills from inventory individually, identifying a source and adistributor of each of the dispensed pills by accessing a database andscanning a machine readable code assigned to each of the pillsindividually.
 14. A method of claim 13, wherein the pills areindividually within single-pill containers.
 15. A method of scanning,comprising scanning a machine readable code while a pill is within acontainer, decoding information pertaining to the pill from the scannedmachine readable code, and evaluating the decoded information andaccessing a database to determine whether taking the pill poses anypotential health risk and, if so, providing a warning.
 16. A method ofclaim 15, wherein the scanning is through a transparent material throughwhich the machine readable code is readable.
 17. A method of claim 15,further comprising recording a time of day in response to the scanning.18. A method of claim 17, further comprising determining efficacy of thepill based in part on the recorded time of day.
 19. A method of claim15, wherein the machine readable code is on the sealed container.
 20. Amethod of claim 16, further comprising effecting record keeping byreading the machine readable code on the sealed container.
 21. A methodof record keeping, comprising scanning a machine readable code on acontainer of at least one pill and storing information pertaining towhat was scanned and a time of day of the scanning, and recordingdietary information at times before, during and after the scanning andcorrelating same with the stored information.
 22. A method in of claim18, further comprising storing information pertaining to food and a timea day when the food is eaten as the dietary information and correlatingwith the stored information.
 23. A method of claim 13, wherein themachine readable code is in a form other than human-readablealpha-numerical characters.
 24. A method of claim 23, wherein theidentifying arises from the scanning upon correlating with informationstored in a data base.
 25. A method of claim 15, wherein the machinereadable code is in a form other than human-readable alpha-numericcharacters.
 26. A method of claim 25, wherein the evaluating is based oncorrelating the machine readable code with information stored in a database.
 27. A method of claim 7, wherein the pills are selected from agroup consisting of tablets, caplets, gel-caps, pellets, gum-pieces,capsules, edible items that are biocompatible that contain anyconsumable herb, chemical, mineral, vitamin, plant or animal product,drug or placebo.
 28. A method of claim 13, wherein the pills areselected from a group consisting of tablets, caplets, gel-caps, pellets,gum-pieces, capsules, edible items that are biocompatible that containany consumable herb, chemical, mineral, vitamin, plant or animalproduct, drug or placebo.
 29. A method of claim 15, wherein the pill isselected from a group consisting of a tablet, a caplet, a gel-cap, apellet, a gum-piece, a capsule, an edible item that is biocompatiblethat contains any consumable herb, chemical, mineral, vitamin, plant oranimal product, drug or placebo.
 30. A method of claim 21, wherein thepill is selected from a group consisting of a tablet, a caplet, agel-cap, a pellet, a gum-piece, a capsule, an edible item that isbiocompatible that contains any consumable herb, chemical, mineral,vitamin, plant or animal product, drug or placebo.
 31. An apparatus toverify that medication to be administered is correct, comprising:scanning equipment suited to effect a scanning a bar code on anidentification bracelet worn by a patient to ascertain patientinformation and to effect a scanning a bar code pertaining to medicationto be administered to the patient to ascertain medication information;verification equipment suited to effect verifying as to whether thepatient information and the medication information is correct andauthorized based on both of the scannings by accessing a network; and analarm arranged to be activated as a consequence of the verifyingindicating that the medication is improper for administration to thepatient.
 32. A system of determining information concerning a pill,comprising dispensing equipment configured to dispense pills frominventory individually, and identification equipment configured andarranged to identify a source and a distributor of each of the pillsdispensed by the dispensing equipment by accessing a database andscanning a machine readable code assigned to each of the pillsindividually.
 33. A system of claim 32, wherein the pills areindividually within single-pill containers.
 34. A system ofadministering medication, comprising: equipment configured to keep trackof each individual one of a plurality of pills by machine reading amachine readable code assigned to each of the individual pills;dispensing equipment configured to effect dispensing of an individualone of the pills based on the machine reading; and equipment configuredto adjust inventory requirements for stocking of the individual pillsbased on the machine reading and the dispensing.
 35. A system suited toscan, comprising scanning equipment suited to scan a machine readablecode while a pill is within a container, decoding equipment configuredand arranged to decode information pertaining to the pill from thescanned machine readable code, and equipment configured and arranged toevaluate the decoded information and to access a database to determinewhether taking the pill poses any potential health risk and, if so,provide a warning.